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A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery

18 Years
Open (Enrolling)
Post-operative Pain, Complications

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Trial Information

A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery


Background Transanal Endoscopic Microsurgery (TEM) is an advanced minimally invasive
endoluminal technique used to remove rectal tumours. In the open transanal excision era,
there is evidence that outcomes in unsutured rectal defects are similar to those in patients
whose defect is closed. However, the evidence for this approach is minimal and technical
differences in TEM (e.g. rectal insufflation) may mean that leaving defects unsutured is not
a safe approach. Further, there is anecdotal evidence that unsutured defects lead to more
postoperative pain and delay recovery.

Objective The purpose of this study is to determine if postoperative pain (primary) and
early postoperative complications (secondary) are worse in patients undergoing TEM and do
not have the defect closed when compare to similar patients who have endoluminal suture
closure of the defect.

Methods This is a multicentre, double blind randomized controlled trial of suture closure
versus no closure in patients treated by TEM for rectal lesions. The study will include
patients 18 years and older with rectal lesions within 12cm of the anal verge treated with
TEM. The primary outcome is postoperative pain as measured by validated visual analogue
scale (VAS). Secondary outcomes include analgesic use and early (<30 day) complications.
Based on anticipated VAS scores, a sample size of 38 patients will be enrolled (power 0.80,
α=0.05). Statistical analysis will be performed using student's T test for continuous data
and Fischer's exact test for dichotomous variables.

Impact Currently, only 3 centres in Canada have experience with TEM: Vancouver, Winnipeg
and Ottawa. This study represents the first trial of a Canadian TEM Collaborative and will
determine if there is an advantage to suture closure of the rectal defect in TEM surgery.
This is important, as suture technique is challenging and if there are important advantages
to this approach, there would be a mandate to perfect suturing technique before employing
the TEM approach to rectal tumours. Conversely, if there is an advantage to leaving the
defect unsutured, this may reduce operative time and facilitate better use of OR time.
Further, it will inform all TEM surgeons of the best approach to the rectal defect and
optimize patient care. Finally, this study will serve as a starting point for further
trials by the Canadian TEM Collaborative that will expand to include new sites and become a
world leader in TEM clinical trials.

Inclusion Criteria:

- The patients must be over 18 years old with a rectal lesion < 12cm from the anal
verge (as measured by rigid sigmoidoscopy) and less than half the circumference of
the rectal lumen. The patient must provide informed consent for TEM and inclusion in
the trial.

Exclusion Criteria:

- The surgeon decides to convert to laparotomy or conventional TAE for any reason
during tumor excision.

- The surgeon judges that the rectal defect is not appropriate for suturing (e.g. too
large) or to be left unsutured (e.g. entry into peritoneal cavity)

- The patient is currently treated for chronic pain prior to surgery, has a known
bleeding diathesis (e.g. warfarin treatment, hemophilia, etc) or is immunosuppressed
(e.g. Prednisone, HIV,etc)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Postoperative Pain

Outcome Description:

As an ancillary measure, all patients will be prescribed 30 tablets of either Tylenol#3 or Tramacet as as their primary postoperative analgesic.

Outcome Time Frame:

1day after surgery

Safety Issue:


Principal Investigator

Carl J Brown, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Paul's Hospital


Canada: Ethics Review Committee

Study ID:




Start Date:

March 2012

Completion Date:

August 2012

Related Keywords:

  • Post-operative Pain
  • Complications
  • TEM for rectal lesions
  • Sutured defect
  • Unsutured defect
  • Pain, Postoperative